UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055933 |
|---|---|
| Receipt number | R000063905 |
| Scientific Title | Questionnaire Survey for Japanese IgA nephropathy patients |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2025/03/31 16:52:38 |
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Basic information
Public title
Questionnaire Survey for Japanese IgA nephropathy patients
Acronym
Questionnaire Survey for Japanese IgA nephropathy patients
Scientific Title
Questionnaire Survey for Japanese IgA nephropathy patients
Scientific Title:Acronym
Questionnaire Survey for Japanese IgA nephropathy patients
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the percentage of symptoms experienced by Japanese patients with IgA nephropathy and the degree to which these symptoms affect their daily lives.
To understand the status of SDM and satisfaction with treatment (actual condition of SDM, intention, satisfaction with treatment, etc.)
Information points of contact in the treatment (sources of information they refer to, information they want to know, information they lack, etc.).
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Presence of (current) IgA nephropathy symptoms
2. Frequency of (current) IgA nephropathy symptoms
3. The impact of each symptom of IgA nephropathy on daily life (for each symptom)
4. The symptoms of IgA nephropathy that particularly affect daily life (rank the symptoms accordingly)
5. No longer able to do daily activities due to IgA nephropathy symptoms.
6. Symptoms of IgA nephropathy that would like to improve (rank the relevant symptoms)
Key secondary outcomes
1. Communication with doctors
2. Actual condition and intention of SDM
3. Satisfaction with treatment
4. Reasons for satisfaction with treatment
5. Sources of information on treatment
6. Information needed or lacking in treatment options
7. Ease of telling others about IgA nephropathy
8. Reasons for reluctance to tell others about IgA nephropathy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with a confirmed diagnosis of IgA nephropathy by renal biopsy.
2. Japanese patients (regardless of gender) aged 18 years or older at the time of consent
Key exclusion criteria
1. Patients currently receiving dialysis treatment.
2. Patients who have undergone renal transplantation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Fukamizu |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Medical Affairs
Zip code
106-0041
Address
1-3-1, Azabudai, Minato-ku, Tokyo, Japan
TEL
03-5656-0400
Yuji.Fukamizu@viatris.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ishikawa |
Organization
3H Medi Solution Inc.
Division name
Insight Solution Promotion Office
Zip code
171-0022
Address
JRE Minami-Ikebukuro Bleg.2F, 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo, Japan
TEL
03-5985-0053
Homepage URL
ishikawa-tatsuya@3h-ms.co.jp
Sponsor or person
Institute
Viatris Pharmaceuticals Japan G.K.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hillside Clinic Jingumae Ethics Committee
Address
4-22-11, Jingumae, Shibuya-ku, Tokyo, Japan
Tel
03-6779-8166
chi-pr-ec-hillside@cmicgroup.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web Questionnaire Study
Management information
Registered date
| 2024 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063905
